APC pitches ‘third way’ at PCAC meeting

APC offered testimony before the FDA’s Pharmacy Compounding Advisory Committee (PCAC) on Thursday (and will again on Friday). Our main point echoed our earlier letter: The agency should consider a “third way” for regulating peptides. Rather than choosing between unrestricted access and an outright ban, we believe the situation calls for a carefully controlled pathway that would allow pharmacies to compound these products under strict safeguards.

This third path doesn’t need to be complex. Start with ensuring that the peptides’ APIs come from FDA-registered resellers that are on a Green List and who are required to conduct testing and COA validation. Enhance patient disclosures so any serious adverse events would be reported via FDA’s MedWatch system. Collect limited prescribing data to help identify potential safety concerns.

That alone would go a long way toward protecting patients, or at least ensuring the peptides they take are quality medications taken under proper supervision.

We were clear that any regulatory decision needs to be coordinated with the pharmaceutical supply chain; manufacturers need time to produce FDA-quality, cGMP-compliant APIs before any kind of compounding should be authorized.

Our point is simple: That kind of carefully managed regulatory framework would strengthen patient safety by encouraging the development of high-quality ingredients, supporting legitimate pharmacy compounding, and helping move patients away from gray- and black-market peptides and into the regulated healthcare system.

So what did PCAC do?

At its Thursday meeting, the committee voted to recommend that the FDA add BPC-157 (both free base and acetate forms) to the 503A Bulks List.

This is a non-binding recommendation, of course, but it’s certainly a major step toward just what we want: smart regulation that helps protect patients from what seems like an ever-expanding gray market for peptides. We’ll keep you updated on PCAC’s votes and, of course, the FDA’s final decisions.